title: Non-invasive metabolomic analysis using a commercial NIR instrument for embryo selection.
abstract: BACKGROUND
  Metabolomics was introduced in human in vitro fertilization (IVF) for noninvasive identification of viable embryos with the highest developmental competence.
  
  
  OBJECTIVE
  To determine whether embryo selection using a commercial version of metabolomic analysis leads to increased implantation rates (IRs) with fetal cardiac activity (FCA) compared with morphology evaluation alone.
  
  
  METHODS
  Randomized controlled trial from April to December 2010 at a private IVF unit. The study was terminated prematurely due to the market withdrawal of the instrument.
  
  
  METHODS
  IVF patients ≥18 and ≤43 years with ≥4 × 2PN were randomly allocated to metabolomic analysis combined with embryo morphology (ViaMetrics-E; metabolomics + morphology group) or embryo morphology alone (morphology group). Cycles with frozen embryos, oocyte donations, or testicular biopsy were excluded.
  
  
  METHODS
  Categorical and continuous data were analyzed for statistical significance using 2-tailed Fisher's exact test and t-test, respectively. Statistical significance was accepted when P > 0.05.
  
  
  RESULTS
  A total of 125 patients were included in the study; 39 patients were allocated to metabolomics + morphology group and 86 patients to morphology group. Patients were stratified according to the day of embryo transfer (Days 2, 3, or 5). IRs with FCA were similar for Days 2 and 3 transfers in both groups. For Day 5 transfers, IRs with FCA were significantly higher in the metabolomics + morphology group (46.8% vs. 28.9%; P = 0.041; 95% confidence intervalp [CI]: 1.09-34.18). Pregnancy and live births rates were similar for Days 2, 3, and 5 in both groups. The study was terminated early following the voluntary market withdrawal of ViaMetrics-E in December 2010.
  
  
  CONCLUSIONS
  Metabolomic analysis using the commercial near-infrared (NIR) instrument does not appear to have a beneficial effect on pregnancy and live births, with improvement in IR with FCA for Day 5 transfers. However, no solid conclusions can be reached due to the lack of adequate study power.ClinicalTrials.gov Identifier: NCT01490515.
authors.affiliation: Eugonia Unit of Assisted Reproduction, Athens, Greece.
authors.forename: Ioannis A
authors.initials: IA
authors.lastname: Sfontouris
authors.forename: George T
authors.initials: GT
authors.lastname: Lainas
authors.forename: Denny
authors.initials: D
authors.lastname: Sakkas
authors.forename: Ioannis Z
authors.initials: IZ
authors.lastname: Zorzovilis
authors.forename: George K
authors.initials: GK
authors.lastname: Petsas
authors.forename: Trifon G
authors.initials: TG
authors.lastname: Lainas
keywords: Embryo selection; implantation rates; metabolomics; near-infrared; noninvasive